The noninferiority of a sirolimus-eluting balloon relative to a paclitaxel-eluting balloon for treating coronary in-stent restenosis regarding late lumen loss was not confirmed (P>0.999).
RCT (n=145)
randomized
Does a sirolimus-eluting balloon catheter reduce in-segment late lumen loss compared to a paclitaxel-eluting balloon catheter in patients with coronary in-stent restenosis?
A novel sirolimus-eluting balloon failed to demonstrate noninferiority to a paclitaxel-eluting balloon for angiographic late lumen loss in patients with coronary in-stent restenosis.
p-value: p=>0.999
BACKGROUND: Current therapy for in-stent restenosis (ISR) is based on drug-eluting stents (DES) or drug-eluting balloon catheters. This prospective randomized study compared the efficacy of a novel sirolimus-eluting balloon (SEB) catheter to that of a paclitaxel-eluting balloon (PEB) catheter for the treatment of bare-metal stent (BMS-ISR) or DES-ISR. METHODS: A total of 145 patients with 158 BMS or DES-ISR lesions were randomly assigned to the treatment with either SEB or PEB. The in-segment late lumen loss at 12 months, the 12-month incidence of binary ISR, and major adverse cardiac events (cardiac death, nonfatal acute myocardial infarction, or target lesion revascularization) were compared between groups. RESULTS: >0.999) between the SEB and PEB groups were observed. CONCLUSIONS: The noninferiority of SEB relative to PEB in the treatment of BMS/DES-ISR with respect to late lumen loss was not confirmed. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03667313.
Pleva et al. (Wed,) conducted a rct in Coronary In-Stent Restenosis (n=145). Sirolimus-eluting balloon (SEB) catheter vs. Paclitaxel-eluting balloon (PEB) catheter was evaluated on In-segment late lumen loss at 12 months (p=>0.999). The noninferiority of a sirolimus-eluting balloon relative to a paclitaxel-eluting balloon for treating coronary in-stent restenosis regarding late lumen loss was not confirmed (P>0.999).